Using Genetic Polymorphisms to Predict the Efficacy and Toxicity - A Gastric Adenocarcinoma Study

Gastric Adenocarcinoma Clinical Trial

Official title:

Using Genetic Polymorphisms of Drug Metabolism and Immunohistochemical Stain to Predict the Efficacy and Toxicity in Patients With Gastric Adenocarcinoma - A Phase II Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01558011
• Other study ID #: T3211
• Secondary ID: 100CT202
• Status: Terminated
• Phase: Phase 2
• First received: March 5, 2012
• Last updated: May 3, 2016
• Start date: March 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2013
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is an open-label, non-comparative phase II study of sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.

Description:

There are two primary objectives in different steps. In the first step, the primary objective of this study is to investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.

In the second step, the primary objective of this study is to screen the predictive biomarkers of three different chemotherapeutic drugs and also investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: December 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Pathologically confirmed gastric adenocarcinoma.

• At least one measurable lesion in a non-irradiated area.

• No prior exposure to systemic chemotherapy for advanced gastric cancer.

• For those have adjuvant chemotherapy after a curative gastrectomy, the last dosing of previous adjuvant chemotherapy should be at least 6 months before the start of this treatment.

• Age > 20 years old.

• ECOG Performance Status 2.

• Life expectancy greater than 12 weeks.

• Adequate bone marrow function :absolutely neutrophil count 1.5 x 109/L or WBC 4 x 109/L; Hemoglobin > 9 g/dl;platelet count 100 x 109/L.

• Adequate liver function : ALT & AST 2.5 x ULN if without liver metastasis or 5 x ULN if with hepatic metastasis. Alkaline phosphatase 2.5 x ULN if without liver metastasis or 5 x ULN, if with hepatic and bone metastasis. Bilirubin < 2 x ULN

• Adequate renal function :Creatinine < 1.5 x ULN.

• Patients must be accessible for treatment and follow-up in the participating centers.

Exclusion Criteria:

• Patient who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.(Previous radiotherapy is allowable if the last dose was given more than 2 weeks before the protocol treatment).

• Major surgery within two weeks prior to entering the study.

• Patients with CNS metastasis, including clinical suspicion.

• Patients who are under active or uncontrolled infections.

• Patients who had cardiac arrhythmia or myocardial infarction history 6 months before entry.

• Patients with clinically detectable peripheral neuropathy > 2 on the CTC criteria

• Patients with concomitant illness that might be aggravated by chemotherapy.

• Patients who are pregnant or with breast feeding.

• Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.

• Patients with hypersensitivity to any component of the chemotherapeutic regimen.

• Mental status is not fit for clinical trial

• Can not take study medication orally

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma

Intervention

Drug:
• Capecitabine, Oxaliplatin, Docetaxel
Capecitabine: 500 mg film coated tablets; Oxaliplatin: 50 mg/ 10 ml; Docetaxel: 20 mg / 0.5ml vial. Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy.

Locations

Country	Name	City	State
Taiwan	National Health Research Institutes	Zhunan	Miaoli

Sponsors (5)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Mackay Memorial Hospital, National Cheng-Kung University Hospital, Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	Tumor responses in measurable lesions are to be evaluated by the tumor response guidelines validated by the Response Evaluation Criteria in Solid Tumors (RECIST) Group . The new version 1.1 was published in 2009.	Every 6 weeks	Yes
Secondary	Progression-free survival	Be calculated as the duration between the first date of randomization and the date of disease recurrence or progression according to RECIST (failed), taking the status of tumor at the treatment has been completed as the reference, or death (failed), or the date of withdrawal (last contact date, censored), or the scheduled data analysis date (censored).	Every 6 weeks	Yes